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A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy

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ClinicalTrials.gov Identifier: NCT00639691
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

March 13, 2008
March 20, 2008
September 29, 2016
January 2005
December 2011   (Final data collection date for primary outcome measure)
Serious Adverse Events from first visit until end of study
Same as current
Complete list of historical versions of study NCT00639691 on ClinicalTrials.gov Archive Site
  • To evaluate reasons for premature discontinuation.
  • All adverse events, duration of study participation.
Same as current
Not Provided
Not Provided
 
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab)in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
Biological: omalizumab
sc
Experimental: 1
Intervention: Biological: omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
50
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female, ≥ 6years of age;
  • who have a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria;
  • severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per Canadian Asthma Consensus Report (1999));
  • Subjects having successfully completed one of the following protocols: CIGE025A011E3, CIGE025A2425, CIGE025AIA05;
  • elevated immunoglobin E levels

Exclusion Criteria:

  • significant systemic disease
  • pregnancy or lactation
  • an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
  • history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
  • current treatment with warfarin (Coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00639691
CIGE025ACA01
Not Provided
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Not Provided
Novartis
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP